DNA Script

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using enzymatic DNA synthesis (EDS) technology. The company aims at accelerating innovation in life science and technology through the decentralization of rapid, on demand and high-quality DNA synthesis. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for customizing nucleic acid synthesis thus accelerating discovery in genetics, genomics, and synthetic biology. Discovery disciplines with profound impacts upon humanity such as biopharma, translational genetics and even molecular information storage all start with synthetic DNA. The company has recently initiated the commercialization of its first EDS powered platform, the SYNTAX system.

To date, DNA Script has raised over $315M of financing, with leading investors such as Coatue Management, Fidelity Management and Research, Catalio Capital Management, Casdin Capital, LSP, Bpifrance Large Ventures, Danaher, Illumina Ventures, Agilent, Merck Ventures, Sofinnova Partners, Kurma Partners, T Rowe Price, Baillie Gifford and Eurazeo.

DNA Script also partners on technology and product development with leading organizations such as DARPA, IARPA, Moderna Therapeutics, GE Research, Illumina, the Broad Institute, Harvard University, Institut Pasteur and the French Department of Defense.

DNA Script has its research and manufacturing facilities headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

Opportunity and Challenges :

We are looking to assemble a team of best-in-class, innovative and passionately eager people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write.” We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our DNA On Demand platform not only has the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impacts across biological sciences.

The role

The Quality Control (QC) department is divided in two teams at DNA Script: one team in France, in charge of performing QC of reagents produced in France and one team in South San Francisco (SSF), in charge of performing the QC of our instruments (Syntax) and the reagents produced in SSF.

We are looking for a QC Manager (US) to create and develop the Quality Control team and activities in SSF. It is an excellent opportunity to create a lab, define a strategy and have a huge impact on fast-growing company.

The QC Manager (US) reports to the Quality and Regulatory Director.

Responsibilities

• Create and structure the QC department for instruments and reagents in SF office
• Hire and manage the QC team, supervise the daily activities of the laboratory
• Develop QC processes in the lab in compliance with ISO requirements to implement best practices
• Support establishment and maintenance of QC labs (lab organization, instrument/equipment calibration, preventative maintenance, purchase, lab cleaning, etc).
• Approve the results obtained, establish CoA and release instruments/reagents
• Perform root cause investigation and lead Quality Operational events related to the department (Out of Specifications results, Nonconformance, CAPA, Change Control, …)
• Review documentation (SOP, Batch Manufacturing Records, Work Instruction, Test Protocol, …)
• Be the point of contact for team concerning Instruments QC-related topics, represent QC in meetings as a QC Subject Matter Expert
• Work closely with the QC team leader based in France (only reagents QC) and various departments to ensure new documentation or processes comply with Quality requirements
• Inspire and foster a strong Quality culture, mentor staff and organization for development and growth
• Perform other duties as assigned

Qualifications and experience

Essential

• Bachelor’s/Master’s Degree or PhD in a related field with minimum of 8 years’ experience in Quality Control in a biotechnology/pharmaceutical setting.
• Familiarity with ISO 9001, ISO 13485, 21CFR820, or biotech manufacturing and a thorough knowledge and understanding of GMP
• Experience in the biotech/pharma industry
• Demonstrated leadership, high organizational and prioritization skills
• Attention to detail and problem solving
• Excellent written and verbal communication skills

Desirable

• Auditor certification,
• Start-up mindset.

Miscellaneous

• Job located in South San Francisco, California
• Start date: As soon as possible.

Benefits:

• Health, Dental, Vision. Company pays 80% of premiums for employees and dependents. We have lots of plans available including HMOs, PPOs, HDHPs, etc.
• Life insurance
• 401(k) with 4% match
• Short and long-term disability insurance
• Other employee-funded plans including pre-tax commuter, HSA, and FSA
• EAP

Recruitment Process:

• Initial screening with the hiring manager
• Day interview at the office (or remote) with the manager, cofounders, HR and the rest of the team
• Reference Checks
• Timing: 2-3 weeks